ESMO 2008 - GSK To Present Encouraging New Data Supporting Late Stage Development Programme

Main Category: Cancer / Oncology
Article Date: 12 Sep 2008 - 5:00 PDT

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At the 33rd meeting of the European Society for Medical Oncology (ESMO) Stockholm, Sweden, GlaxoSmithKline (GSK) Oncology will present exciting new data for Tyverb® (lapatinib) and pazopanib. These new data form the foundation of Phase III development plans for these molecules across a variety of tumours including Head and Neck, Ovarian, Lung, and Soft Tissue Sarcoma.

GSK will also present data for the anti-emetic neurokinin-1 receptor antagonist, Zunrisa™ (casopitant); the oxidative stress inducer, elesclomol, for metastatic melanoma and the antigen-specific cancer immunotherapeutic, MAGE-A3 ASCI, for non-small cell lung cancer and metastatic melanoma.

These data represent a significant level of growth within GSK's oncology portfolio - demonstrating the Company's commitment to oncology and the strength of its late stage pipeline.

Newly Integrated 'GSK Oncology'

Today, GSK also announced the formation of a newly integrated Oncology Research and Development Organisation. GSK Oncology brings together small discovery units (DPUs) within the existing CEDD, and a highly specialised drug development group to create a dedicated oncology research and development organisation, led by Paolo Paoletti, M.D., Senior Vice President Oncology Research and Development.

"GSK has designed this new organisation to help us increase the breadth and depth of our core oncology knowledge, in order to ultimately deliver more innovative medicines that enhance cancer patients' lives", said Paoletti. "By creating an end-to-end R&D unit we are able to capture the many synergies that exist between discovery and development in oncology. The application of translational medicine will bring about significant enhancements to the R&D group via the 'bench to bed' connection - the constant loop and flow of information from early to late stage development, and vice-versa."

"The newly formed GSK R&D Oncology Unit is directly aligned with our R&D strategy to deliver more products of value, and will help us increase our efforts towards personalised medicine in oncology," said Moncef Slaoui, Chairman, Research and Development. "This dedicated unit will have the primary goals of identifying new targets and pathways, conducting innovative clinical research and cost-effectively increasing development capacity in order to deliver the unit's large portfolio of medicines."

GlaxoSmithKline - one of the world's leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit http://www.gsk.com

Key Oral Presentations

#688O - Effect of lapatinib monotherapy on apoptosis and proliferation: results of a phase II randomised study in patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN) will be presented during the ESMO Head and Neck Cancer oral presentation session on Sunday 14, September, 10.00 - 10.15 CET. Presenter: Dr J M Del Campo.

#225O - Phase II study of pazopanib (GW786034) given preoperatively in stage I-II non-small cell lung cancer (NSCLC): A proof of concept study will be presented during the Chest Tumors oral presentation session on Monday 15, September, 10.45 - 11.00 CET. Presenter: Dr N Altorki.

#663O - Pazopanib (GW786034) is active in women with advanced epithelial ovarian, fallopian tube and peritoneal cancers; results of a phase II study will be presented during the ESMO Gynecological Cancer oral presentation session on Monday 15, September 10.45 - 11.00 CET. Presenter: Dr M Friedlander.

#868O - Pazopanib in patients with relapsed or refractory soft tissue sarcoma (STS); A phase II study from the EORTC STBSG (EORTC62043) will be presented during the ESMO Sarcoma Cancer oral presentation session on Monday 15, September, 14.30 - 14.45 CET. Presenter: Dr S Sleijfer.

ESMO Highlights

ESMO has selected two pazopanib abstracts for inclusion in their official ESMO press conference:

Results of a Phase II study of pazopanib in non-small cell lung cancer will be presented at the ESMO Press Breakfast, Saturday 13 September, 09.30 - 10.30 CET

Results of a Phase II study of pazopanib in women with advanced epithelial ovarian, fallopian tube and peritoneal cancers will be presented at the ESMO Press Conference, Saturday 13 September, 12.30 - 13.30 CET

To access the latest GSK Oncology media materials, visit http://www.gskcancermedia.com

CEDD: Centre of Excellence for Drug Discovery

-- TYKERB® is a registered trademark of the GlaxoSmithKline group of companies in the United States.
-- TYVERB® is a registered trademark of the GlaxoSmithKline group of companies in Europe and is the proposed trade name in certain markets, pending regulatory approval.
-- Lapatinib is approved for sale in more than 55 countries including the United States, Europe, Australia, New Zealand, Switzerland, South Korea and certain countries in South America and the Middle East.
-- Registration dossiers for lapatinib have been filed in Canada and a number of countries in Asia, Latin America and the Middle East.
-- ZUNRISA™, the proposed trade name for casopitant, is a trademark of the GlaxoSmithKline group of companies.
-- Casopitant is not approved for marketing by any regulatory body in any country.
-- Pazopanib is not approved for marketing by any regulatory body in any country.
-- MAGE-A3 ASCI is not approved for marketing by any regulatory body in any country.
-- Elesclomol is not approved for marketing by any regulatory body in any country. Elesclomol is being developed under a global collaboration agreement between Synta Pharmaceuticals and GlaxoSmithKline.

GlaxoSmithKline